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Ischemic StrokePhase 2/3TALISMANNCT02180204

Tenecteplase Versus Alteplase in Ischemic Stroke Management (TALISMAN)

A Phase 2/3 study testing Tenecteplase and Alteplase in people with Ischemic Stroke, run by Reza Behrouz, DO at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a double-blind parallel arm randomized trial aimed to assess efficacy and safety of intravenous Tenecteplase compared to intravenous Alteplase in eligible patients who present with symptoms of acute ischemic stroke within 3 to 4.5 hours from onset. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Ischemic Stroke
What is being tested?
Tenecteplase and Alteplase
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Jan 2015to Jun 2020
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 to 80 years
  • Acute neurologic deficit with an NIHSS ≥ 4
  • Non-enhanced computed tomography (NECT) of the head showing no hemorrhage
  • Acute ischemic stroke symptoms with onset, or time last known well, clearly defined between 3 and 4.5 hours
  • Treatment can be initiated within 3 to 4.5 hours from symptom onset

Who cannot join

  • Evidence of intracranial hemorrhage on NECT
  • Clinical suspicion of subarachnoid hemorrhage even with normal NECT
  • NECT shows hypo-density greater than 1/3 cerebral hemisphere)
  • History of intracranial hemorrhage/stroke
  • Uncontrolled HTN: At time treatment begins SBP remains >185 mmHg or DBP remains >110 mmHg despite repeated measurements
  • Known arteriovenous malformation, neoplasm, or aneurysm
Show all 29Show fewer
  • Witnessed seizure at stroke onset
  • Acute bleeding tendencies
  • Platelet count <100,000/mm3
  • Heparin received in prior 48 hours with elevated aPTT
  • Current use of an anticoagulant (Coumadin/Warfarin) irrespective of INR
  • Prior use (within 48 hours) of direct thrombin inhibitors (dabigatran) or direct factor Xa inhibitors (rivaroxaban, apixaban)
  • Within prior 3 months: intracranial or spinal surgery, head trauma, or previous stroke
  • Arterial puncture at non-compressible site within last 7 days
  • Woman of child bearing age who has a positive pregnancy test
  • NIH stroke scale >25 (severe deficit) or <4 and no dysphasia (mild deficit) or rapidly improving
  • Symptoms spontaneously clearing
  • 14 days post-operative or post major trauma
  • Recent gastrointestinal or urinary tract hemorrhage within the past 21 days
  • Recent acute MI within the past 3 months
  • Serum glucose <50 mg/dl or >400 mg/dL
  • Age >80 or less than 18
  • History of ischemic stroke AND diabetes mellitus
  • Unable to obtain consent from patient or power of attorney
  • Baseline mRS > 2
  • Consent not obtained by 20 minutes prior to closure of the therapeutic window.
  • The subject has been treated with a thrombolytic agent within the past 72 hours
  • The subject is a pregnant woman (positive serum βHCG pregnancy test, positive urine pregnancy test or clinically evident pregnancy)
  • The subject is, in the opinion of the investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The Ohio State University College of Medicine

    Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: Phase IIb Study Comparing Tenecteplase to Alteplase in Acute Ischemic Stroke Within 3 to 4.5 Hours From Symptom Onset

This is a double-blind parallel arm randomized trial aimed to assess efficacy and safety of intravenous Tenecteplase compared to intravenous Alteplase in eligible patients who present with symptoms of acute ischemic stroke within 3 to 4.5 hours from onset.

Read the detailed description

Patients presenting with symptoms of acute ischemic stroke (AIS) who present within 3 to 4.5 hours of symptom onset and who meet the inclusion criteria for intravenous (IV) thrombolysis will receive, in a randomized, double-blind fashion, either IV Alteplase at 0.9 mg/kg per standard protocol or IV Tenecteplase at 0.25 mg/kg with saline infusion over one hour. Patients must also have no exclusion criteria for IV thrombolysis within the 3 to 4.5 hour window. The only required imaging is non-contrasted CT of the head. Patients will be monitored according to standard post-thrombolytic care. A CT of the head will be performed at 24 hours based on standard protocol or if there is any neurological change. Neurological function at 24 hours using NIHSS and at 3 months based on modified mRS and the NIHSS.

Conditions
Ischemic Stroke
Being tested
Tenecteplase, Alteplase
Keywords
Cerebral Infarction, Ischemic Stroke, Thrombolysis
Medical subject headings
Ischemic Stroke, Cerebral Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TenecteplaseDrug

    Also called TNKase

    Tenecteplase 0.25 mg/kg IV - Maximum 25 mg

  • AlteplaseDrug

    Also called Activase, t-PA

    Alteplase 0.9 mg/kg IV - Maximum: 90 mg

Study groups in NCT02180204
Study groupRoleWhat they receive
TenecteplaseExperimentalTenecteplase 0.25 mg/kg IV - Maximum dose: 25 mg
Receives: Drug: Tenecteplase
AlteplaseActive comparatorAlteplase 0.9 mg/kg IV - Maximum dose: 90 mg
Receives: Drug: Alteplase

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neurological outcome

    Measured by modified Rankin Scale score

    Measured: 90 days

Secondary outcomes (1)

  1. Symptomatic intracranial hemorrhage

    Twenty-four hour brain CT scan showing intracranial hemorrhage in conjuction with neurological deterioration of 4 points or more on the NIHSS

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2014 (estimated)
  2. Study startJan 2015
  3. Primary completionJun 2020 (estimated)
  4. Study completionJun 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02180204
Sponsor's protocol ID
2013H000
Other IDs
TALISMAN
Acronym
TALISMAN
Status last verified
Sep 2015
First submitted
21 Jun 2014
Last updated
23 Sep 2015
Results posted
No
Data monitoring committee
No

Publications

  • Parsons M, Spratt N, Bivard A, Campbell B, Chung K, Miteff F, O'Brien B, Bladin C, McElduff P, Allen C, Bateman G, Donnan G, Davis S, Levi C. A randomized trial of tenecteplase versus alteplase for acute ischemic stroke. N Engl J Med. 2012 Mar 22;366(12):1099-107. doi: 10.1056/NEJMoa1109842.

    PubMed 22435369

  • Parsons MW, Miteff F, Bateman GA, Spratt N, Loiselle A, Attia J, Levi CR. Acute ischemic stroke: imaging-guided tenecteplase treatment in an extended time window. Neurology. 2009 Mar 10;72(10):915-21. doi: 10.1212/01.wnl.0000344168.05315.9d.

    PubMed 19273826

  • Haley EC Jr, Thompson JL, Grotta JC, Lyden PD, Hemmen TG, Brown DL, Fanale C, Libman R, Kwiatkowski TG, Llinas RH, Levine SR, Johnston KC, Buchsbaum R, Levy G, Levin B; Tenecteplase in Stroke Investigators. Phase IIB/III trial of tenecteplase in acute ischemic stroke: results of a prematurely terminated randomized clinical trial. Stroke. 2010 Apr;41(4):707-11. doi: 10.1161/STROKEAHA.109.572040. Epub 2010 Feb 25.

    PubMed 20185783

  • Haley EC Jr, Lyden PD, Johnston KC, Hemmen TM; TNK in Stroke Investigators. A pilot dose-escalation safety study of tenecteplase in acute ischemic stroke. Stroke. 2005 Mar;36(3):607-12. doi: 10.1161/01.STR.0000154872.73240.e9. Epub 2005 Feb 3.

    PubMed 15692126

  • Lees KR, Bluhmki E, von Kummer R, Brott TG, Toni D, Grotta JC, Albers GW, Kaste M, Marler JR, Hamilton SA, Tilley BC, Davis SM, Donnan GA, Hacke W; ECASS, ATLANTIS, NINDS and EPITHET rt-PA Study Group; Allen K, Mau J, Meier D, del Zoppo G, De Silva DA, Butcher KS, Parsons MW, Barber PA, Levi C, Bladin C, Byrnes G. Time to treatment with intravenous alteplase and outcome in stroke: an updated pooled analysis of ECASS, ATLANTIS, NINDS, and EPITHET trials. Lancet. 2010 May 15;375(9727):1695-703. doi: 10.1016/S0140-6736(10)60491-6.

    PubMed 20472172

  • Behrouz R. Intravenous tenecteplase in acute ischemic stroke: an updated review. J Neurol. 2014 Jun;261(6):1069-72. doi: 10.1007/s00415-013-7102-0. Epub 2013 Sep 15.

    PubMed 24036924

  • Logallo N, Kvistad CE, Thomassen L. Therapeutic Potential of Tenecteplase in the Management of Acute Ischemic Stroke. CNS Drugs. 2015;29(10):811-8. doi: 10.1007/s40263-015-0280-9.

    PubMed 26387127

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Tenecteplase and Alteplase in people with Ischemic Stroke, run by Reza Behrouz, DO at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 23 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neurological outcome (time frame: 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02180204, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2015.

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